333.2682 Statewide network of cord blood stem cell banks
Sec. 2682.
(1) If funding is made available, the department shall establish a statewide network of cord blood stem cell banks. The director of the department shall enter into contracts with qualified cord blood stem cell banks to assist in the establishment, provision, and maintenance of the network.
(2) A cord blood stem cell bank is eligible to enter the network and be a donor bank if it satisfies each of the following:
(a) Has obtained all applicable federal and state licenses, accreditations, certifications, registrations, and other authorizations required to operate and maintain a cord blood stem cell bank.
(b) Has implemented donor screening and cord blood collection practices adequate to protect both donors and transplant recipients and to prevent transmission of potentially harmful infections and other diseases.
(c) Has established a system of strict confidentiality to protect the identity and privacy of patients and donors in accordance with existing federal and state law and consistent with regulations promulgated under the health insurance portability and accountability act of 1996, Public Law 104-191, for the release of the identity of donors, recipients, or identifiable records.
(d) Has established a system for encouraging donation by an ethnically and racially diverse group of donors.
(e) Has developed adequate systems for communication with other cord blood stem cell banks, transplant centers, and physicians with respect to the request, release, and distribution of cord blood units nationally and has developed such systems, consistent with the regulations promulgated under the health insurance portability and accountability act of 1996, Public Law 104-191, to track recipients' clinical outcomes for distributed units.
(f) Has developed an objective system for educating the public, including patient advocacy organizations, about the benefits of donating and utilizing cord blood stem cells in appropriate circumstances.
(3) A donor bank that enters into the network shall do all of the following:
(a) Acquire, tissue-type, test, cryopreserve, and store donated units of human cord blood acquired with the informed consent of the donor, in a manner that complies with applicable federal regulations.
(b) Make cord blood units collected under this section, or otherwise, available to transplant centers for stem cell transplantation.
(c) Allocate up to 10% of the cord blood inventory each year for peer-reviewed research. This quota may be met by using cord blood units that did not meet the cell count standards necessary for transplantation.
(4) A board of directors shall govern and administer the state cord blood stem cell bank network. The board shall be appointed by the director and consist of members who represent each of the following:
(a) Cord blood stem cell transplant centers.
(b) Physicians from participating birthing hospitals.
(c) The cord blood stem cell research community.
(d) Recipients of cord blood stem cell transplants.
(e) Family members who have made a donation to a statewide cord blood stem cell bank.
(f) Individuals with expertise in the social sciences.
(g) Members of the general public.
(h) Each network donor bank.
(5) Except as otherwise provided under this subsection, each member of the board shall serve for a 3-year term and may be reappointed for 1 or more additional terms. Appointments for the initial members shall be for terms of 1, 2, and 3 years, respectively, so as to provide for the subsequent appointment of an equal number of members each year. The board shall elect a chairperson and do each of the following:
(a) Ensure that the donor banks within the network meet the requirements of subsection (2) on a continuing basis.
(b) Encourage network donor banks to work collaboratively with other network donor banks and encourage network donor banks to focus their resources in their respective local or regional area.
(c) Designate 1 or more established national or international cord blood registries to serve as a statewide cord blood stem cell registry.
(d) Coordinate the donor banks in the network.
History: Add. 2006, Act 637, Imd. Eff. Jan. 4, 2007
Popular Name: Act 368
© 2007 Legislative Council, State of Michigan
Legislative Council Administrator LCA Phone 517-373-0212
Votes:4
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